Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

NCT ID: NCT00111475

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-01
• Study Completion Date: 2004-06-17

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.

Conditions

Idiopathic Thrombocytopenic Purpura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A: Romiplostim 0.2 µg/kg

Participants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Administered by subcutaneous injection

Part A: Romiplostim 0.5 µg/kg

Participants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Administered by subcutaneous injection

Part A: Romiplostim 1.0 µg/kg

Participants received 1.0 µg/kg romiplostim subcutaneously on day 1 and on day 15 or 22 depending on platelet counts.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Administered by subcutaneous injection

Part A: Romiplostim 3 µg/kg

Participants received 3.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Administered by subcutaneous injection

Part A: Romiplostim 6 µg/kg

Participants received 6.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Administered by subcutaneous injection

Part A: Romiplostim 10 µg/kg

Participants received 10.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Administered by subcutaneous injection

Part B: Placebo

Participants received placebo subcutaneously once a week for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered by subcutaneous injection

Part B: Romiplostim 1.0 µg/kg

Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Administered by subcutaneous injection

Part B: Romiplostim 3.0 µg/kg

Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Administered by subcutaneous injection

Part B: Romiplostim 6.0 µg/kg

Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Administered by subcutaneous injection

Interventions

Romiplostim

Administered by subcutaneous injection

Intervention Type: DRUG

Placebo

Administered by subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

AMG 531; NPLATE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment
• Have completed at least 1 prior treatment for ITP
• Two (including day -2) of the 3 platelet counts taken during the screening and pre-treatment periods must have fulfilled the following:

• less than 30 x 10^9/L for those subjects not receiving any ITP therapy,
• less than 50 x 10^9/L for those subjects receiving any ITP therapy
• Eastern Cooperative Oncology Group performance status of 0 to 2
• Serum creatinine concentration ≤ 2 mg/dL (≤ 176.8 µmol/L)
• Adequate liver function, as evidenced by a serum bilirubin ≤ 1.5 times the laboratory normal range
• Hemoglobin greater than 10.0 g/dL
• Written informed consent

Exclusion Criteria

• Considered a substantial risk for adverse outcomes because of a clinically important trend (as determined by the investigator) detected in the platelet counts during the screening period
• Any known history of bone marrow stem cell disorder
• Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization
• Documented diagnosis of arterial thrombosis (ie, stroke, transient ischemic attack, or myocardial infarction) in the previous year; history of venous thrombosis (ie, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy
• Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [New York Heart Association (NYHA) greater than class II], uncontrolled hypertension [diastolic greater than 100 mmHg] or cardiac arrhythmia)
• Have 3 or more of the following predisposing factors for thromboembolic events: diabetes; smoker using oral contraceptives; hypercholesteremia (> 240 mg/dL); treatment for hypertension
• Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
• Received any treatment for ITP (except for a constant dose schedule of corticosteroids) within 4 weeks before the screening visit
• Received intravenous (IV) immunoglobulin (Ig) or WinRho within 2 weeks before the screening visit
• Received hematopoietic growth factors, including interleukin (IL)-11 (Neumega®) within 4 weeks before the screening visit
• Past or present participation in any study evaluating polyethylene glycol recombinant human magakaryopoiesis differentiating factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO), or related platelet product
• Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
• Received any monoclonal antibody (eg, rituximab) within 16 weeks before the screening visit or anticipated use during the time of the proposed study
• Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication before the screening period
• Less than 2 months since major surgery (including laparoscopic splenectomy)
• Pregnant or breast feeding
• Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.

Reference Type: BACKGROUND

PMID: 28411254 (View on PubMed)

Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen CF, Nichol JL. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med. 2006 Oct 19;355(16):1672-81. doi: 10.1056/NEJMoa054626.

Reference Type: BACKGROUND

PMID: 17050891 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_46_AMP-2_20000137.pdf

To access clinical trial results information click on this link

http://www.nplate.com/

FDA-approved Drug Labeling

Other Identifiers

20000137

Identifier Type: -

Identifier Source: org_study_id